20 Aug
|
Amulya Corporate Services
|
Vapi
20 Aug
Amulya Corporate Services
Vapi
Role: Microbiologist
Department: Quality Control / Microbiology
Reports To: Microbiology Section Head / QC Manager
Location: Vapi, Gujarat
Employment Type: Full-Time
Company Overview
A leading pharmaceutical manufacturing company committed to producing safe, effective, and high-quality drug products in compliance with cGMP and regulatory standards. We are seeking a detail-oriented Microbiologist to join our Quality Control team.
Job Summary
The Microbiologist will be responsible for performing microbiological testing of raw materials, in-process samples, finished products, water systems, and environmental monitoring to ensure compliance with cGMP, pharmacopoeial standards (USP/BP/EP/IP), and regulatory requirements. The role involves executing tests accurately, documenting results, and supporting investigations related to microbial contamination.
Key Responsibilities
- Perform microbiological testing including Bioburden, Sterility Testing, Bacterial Endotoxin Test (BET/LAL), Microbial Limit Test (MLT), and Growth Promotion Test.
- Conduct Environmental Monitoring (EM)
of cleanrooms, including viable and non-viable particle counts, surface monitoring, air sampling, and personnel monitoring.
- Test water systems (Purified Water, Water for Injection) as per schedule.
- Perform identification of isolated microorganisms using conventional and/or automated identification systems.
- Maintain and calibrate microbiology lab equipment (autoclaves, incubators, laminar air flow units, biosafety cabinets).
- Prepare, sterilize, and control culture media, reagents, and biological indicators.
- Document all testing activities in compliance with GDP (Positive Documentation Practices) and maintain accurate laboratory records/logbooks.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) microbiological results, and support root cause analysis and CAPA.
- Ensure adherence to cGMP, GLP, and safety protocols within the microbiology laboratory.
- Participate in method valid
📌 Microbiologist (Vapi)
🏢 Amulya Corporate Services
📍 Vapi